Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006. [electronic resource]
- Journal of clinical pharmacology Feb 2008
- 146-56 p. digital
Publication Type: Journal Article
0091-2700
10.1177/0091270007311111 doi
Clinical Trials as Topic--methods Decision Making Drug Approval--legislation & jurisprudence Drug Industry--legislation & jurisprudence Government Regulation Guidelines as Topic Humans Investigational New Drug Application--legislation & jurisprudence Legislation, Drug--standards Organizational Objectives Time Factors United States United States Food and Drug Administration--legislation & jurisprudence